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Minimally Invasive Procedure Prevents Stroke
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By Amanda Gardner, HealthDay Reporter

WEDNESDAY, Oct. 6 (HealthDayNews) -- A minimally invasive procedure for a major cause of stroke appears to be as effective as traditional surgery.

For patients with carotid-artery disease or narrowing of the carotid artery -- the main artery supplying the brain -- due to plaque buildup, a procedure combining angioplasty with a filtering device "is not inferior" to carotid endarterectomy, reported a study in the Oct. 7 issue of the New England Journal of Medicine. The latter procedure involves cutting opening the artery and scraping away the plaque.

This and other data played a part in the recent U.S. Food and Drug Administration approval of the filtering device, which will help make the procedure more widely available.

Traditionally, people with this condition undergo general anesthesia while surgeons make a six-inch incision in the neck, open the artery, clear out the plaque, then sew the artery back up again. "This works well, but there can often be complications in patients who are older or who have heart disease or lung disease -- patients who aren't completely healthy," said study author Dr. Jay S. Yadav, director of vascular intervention at the Cleveland Clinic Foundation in Ohio. These not-completely-healthy individuals make up a sizable proportion of the patient population.

Angioplasty, which involves inserting a balloon and installing a stent to widen the artery, has not been a good candidate for carotid-artery disease because it can dislodge debris, which could then travel to the brain.

"People have been a little hesitant to do it in the carotid artery," explained Dr. Peter G. Kalman, chief of vascular surgery and director of multidisciplinary endovascular programs at Loyola University Medical Center in Illinois. "It won't hurt in the foot or elsewhere, but it could have consequences for the brain."

In 2000, however, a small filtering device became available. It acts as a safety net, trapping the debris before it can do any damage.

"That was the key part of the technology that let us do this trial using a filter and a self-expanding stent," Yadav said. The new procedure is done with the patient awake, leaves no scar, and may involve as little as one night in the hospital.

Yadav's study randomly assigned 334 high-risk patients to either one of the two procedures.

After one year of follow-up, 20 patients (12.2 percent) who had undergone the new procedure had had a heart attack or stroke or had died, compared with 32 patients (20.1 percent) in the endarterectomy group. Only 0.6 percent of those who had received stents needed a repeat procedure, vs. 4.3 percent of those in the other group.

According to an accompanying editorial, while the data was roughly equivalent when it came to strokes and death, stenting had better outcomes when it came to heart attacks.

"We found that the less-invasive treatment was at least as safe -- and in some ways, safer -- than the surgery," Yadav confirmed.

The procedure should start becoming more widely available, aided by the FDA approval and imminent Medicare reimbursement, Yadav said. Physicians will, of course, need to be trained in the procedure.

For now, the procedure should be used only in high-risk patients, as that is the only group for which experts have evidence. Because it is so much less invasive, eventually it may become commonplace for lower-risk individuals as well. "We are starting some studies in low-risk patients," Yadav said.

"We don't know where it's going to shake out. I don't think one can just jump on it and say everyone should do it but, it looks interesting," Kalman said. "This at least widens my armamentarium to select the best thing for each individual patient."

More information

For more on carotid-artery disease, visit the American Heart Association (www.americanheart.org ).

SOURCES: Jay S. Yadav, M.D., director, vascular intervention, Cleveland Clinic Foundation, Cleveland; Peter G. Kalman, M.D., chief, division of vascular surgery, and director, multidisciplinary endovascular programs, Loyola University Medical Center, and professor, surgery, Loyola University Chicago Stritch School of Medicine, Maywood, Ill.; Oct. 7, 2004, New England Journal of Medicine

Copyright � 2004 ScoutNews, LLC. All rights reserved.

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